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(Sharecast News) - Specialist drug discovery and development company ImmuPharma announced what it called "an important regulatory milestone" on Monday, in preparation for the new optimised international phase 3 trial of 'Lupuzor' for the autoimmune disease systemic lupus erythematosus.
The AIM-traded firm said its licensing partner, Avion Pharmaceuticals, has submitted a special protocol assessment request to the US Food and Drug Administration (FDA).
It said the special protocol assessment process would see sponsors reach an agreement with the FDA on the design and size of clinical trials, so that they adequately address scientific and regulatory requirements for a study that could support marketing approval.
The previous phase 2 clinical trial of Lupuzor in systemic lupus erythematosus was also carried out under ImmuPharma's special protocol assessment.
ImmuPharma said the review period for such an assessment request was up to 45 days.
"On 28 November 2019, ImmuPharma and Avion signed an exclusive licence and development agreement and trademark agreement for Lupuzor, with Avion agreeing to fund a new international phase 3 trial and commercialising Lupuzor in the US," the board explained in its statement.
"Since then, both companies have been working closely on the clinical trial design and strategy, bolstered by consultation with an eminent group of key opinion leaders.
"This tripartite phase 3 protocol development approach provided thorough and detailed support for developing the most relevant clinical trial for Lupuzor in systemic lupus erythematosus patients."
The company said data and results from the first phase 3 clinical study were analysed and considered in detail and, as a result, a new optimised international phase 3 study protocol had been finalised, and was now the subject of the special protocol assessment request to the FDA.
"The new Phase III study design will be communicated to the market at a later date, once agreed with the FDA."
At 1459 BST, shares in ImmuPharma were up 1.5% at 15.25p.
21 Oct 2014 11:19